NCT00205452

Brief Summary

The only established treatment for the complete resolution of hyperparathyroidism is the surgical removal of the affected glands. While proven as a means of resolving hyperparathyroidism, there have been no comprehensive preoperative and postoperative assessments to determine quality of life for patients undergoing minimally invasive vs. traditional parathyroid surgery. Quality of life will be assessed in subjects undergoing minimally invasive procedures and traditional procedures using a clinically validated survey. We will gather data one week preoperatively as well as one week and one year postoperatively then compare the survey results from the two study groups to each other. We will also compare the study groups to a control group consisting of patients undergoing thyroid surgery. Our ultimate goal is to clarify if minimally invasive parathyroid surgery techniques contribute to a higher patient quality of life as compared to traditional techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

5.3 years

First QC Date

September 13, 2005

Last Update Submit

October 16, 2012

Conditions

Parathyroidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing parathyroid surgery

You may qualify if:

  • parathyroidectomy

You may not qualify if:

  • subjects under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Herbert Chen, MD

    University of Wisconsin Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

US(1)